FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
95209–95232 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 1997
KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
K964401 · FMT
Ludlow Technical Products
General Hospital · 94d
Cleared Feb 06, 1997
OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964493 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC
K964496 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
CERALAS DIODE LASER SYSTEM (CERALAS D15)
K964497 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 90d
Cleared Feb 06, 1997
SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964501 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964512 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
DEPUY DUPONT PHANTOM SUTURE ANCHOR
K964521 · MAI
Depuy, Inc.
Orthopedic · 86d
Cleared Feb 06, 1997
ULTRAFERA WOUND DRESSING
K964614 · KMF
American White Cross, Inc.
General & Plastic Surgery · 80d
Cleared Feb 06, 1997
TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM
K964623 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 80d
Cleared Feb 06, 1997
UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE
K964655 · JDI
Howmedica Corp.
Orthopedic · 78d
Cleared Feb 06, 1997
ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K964786 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 69d
Cleared Feb 06, 1997
ORATEC INTERVENTIOUNS ELECTROSURGICAL PROBES
K965007 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 52d
Cleared Feb 06, 1997
GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS...
K965038 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 51d
Cleared Feb 06, 1997
STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)
K965169 · JJT
Specialized Assays, Inc.
Chemistry · 44d
Cleared Feb 06, 1997
LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
K970009 · JTO
Microbiologics, Inc.
Microbiology · 35d
Cleared Feb 06, 1997
HCG CONTROLS
K970176 · JJX
International Newtech Development, Inc.
Chemistry · 20d
Cleared Feb 05, 1997
SUGITA AVM MICROCLIP
K960037 · HCH
Mizuho America, Inc.
Neurology · 399d
Cleared Feb 05, 1997
PLANNED SOPHIED CLASSIC
K962105 · IZH
Planmed OY
Radiology · 250d
Cleared Feb 05, 1997
DENTINSENSE
K964735 · KLE
Centrix, Inc.
Dental · 72d
Cleared Feb 05, 1997
AT 62 EEG (A.K.A THE A
K965006 · HCC
Stoelting Co.
Neurology · 51d
Cleared Feb 04, 1997
SAFE MICRO
K953976 · DTZ
Polystan A/S
Cardiovascular · 531d
Cleared Feb 04, 1997
ACCESS CHLAMYDIA ASSAY
K960850 · LJC
Bio-Rad Laboratories, Inc.
Microbiology · 340d
Cleared Feb 04, 1997
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
K961024 · KTN
Princeton BioMeditech Corp.
Immunology · 327d
Cleared Feb 04, 1997
RAPID GRAM-POSITIVE ID SYSTEM
K961730 · LQL
Becton Dickinson Microbiology Systems
Microbiology · 277d